Actively Recruiting
Interventional Software for Multi-immunotherapy of Solid Tumors
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-27
60
Participants Needed
1
Research Sites
508 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor
I
Immuno (Guangzhou) Biomedicine S&T Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by intra-tumor (IT) injection of multiple drugs including CTLA4, PD1, and/or PDL1 antibodies combined with drugs-eluting beads loaded with IL2, chemodrug, anti-angiogenesis drug, et. al that will be recommended by an AI-based medical software named IRSW-MIM developed by a cooperating company.
CONDITIONS
Official Title
Interventional Software for Multi-immunotherapy of Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of cancer by cytohistology
- Signed informed consent before joining the trial
- Age over 18 years with expected survival longer than 3 months
- Child-Pugh class A or B with Child score over 7; ECOG score less than 2
- Acceptable coagulation function or reversible coagulation disorders
- Laboratory tests within 7 days before procedure meeting specified blood counts and organ function levels
- At least one measurable tumor lesion according to RECIST v1.1
- Use of birth control methods
- Willingness and ability to comply with visits, treatment, and laboratory tests
You will not qualify if you...
- Participation in another clinical trial of equipment or drugs within the last 4 weeks
- Presence of ascites, hepatic encephalopathy, or bleeding from esophageal or gastric varices
- Serious accompanying diseases affecting prognosis such as heart disease, uncontrolled diabetes, or psychiatric disorders
- History or presence of other tumors or malignancies
- Pregnancy or lactation without use of birth control during treatment
- Poor compliance with treatment or study requirements
- Contraindications for hepatic arterial infusion including impaired clotting, renal failure requiring dialysis, severe atheromatosis, uncontrolled hypertension above 160/100 mmHg
- Allergy to contrast agents
- Use of agents affecting absorption or pharmacokinetics of study drugs
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Z
Zhenfeng Zhang, MD, PhD
CONTACT
B
Bingjia He, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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